Life Sciences W W W . C B I N E T . C O M / T R A N S P A R E N C Y

CONSULTING LEADERS CIRCLE Bronze Sponsor

TECHNOLOGY LEADERS CIRCLE Silver Sponsor

A U G U S T 1 7 - 1 9 , 2 0 1 5 | T H E R I T Z - C A R L T O N | W A S H I N G T O N , D C

Benchmark Winning Frameworks for Successful Compliance and Commercial ProgramsGlobal Transparency • Open Payments Reporting • HCP Relationships • Data Analytics

Transparency & Aggregate Spend

9th Annual Forum on

Doug Brown, MHS, Group Director, Data Sharing & Partnership Group, Center for Program Integrity, Centers for Medicare & Medicaid Services (CMS)

Andrew Powrie-Smith, Director of Communications, European Federation of Pharmaceutical Industries and Associations (EFPIA)

A. FULL DAY WORKSHOP Transparency Reporting for Dental Manufacturers

B. Transparency Reporting in Clinical Research — Optimizing Relationships with Teaching Hospitals and Academic Research Organizations

C. Global Customer and Vendor Master Data Management

I. Global Transparency Programs

II. Data Analytics for Shared Intelligence

Keynote Speakers

Dynamic Workings Groups:6• Ensure Data Integrity of the Customer Master

• Timely Reporting of Indirect Payments — Working with Third-Party Vendors

• Fair Market Value of HCP and Investigator Payments

• Ensure Successful IT and Data Accuracy for Global Transparency

• Navigate Compliance with CMS Final Rule Adjustments

• Match and Validate Covered Recipient Data in Open Payments

• Strategies to Reduce Compliance Risks and Optimize Commercial Programs Using Transparency Data Analytics

• Recent State Reporting Requirements and Enforcement Trends

• Transparency-Related Federal Law Enforcement Trends including FCPA, Anti-Kickback, Off-Label and More

• Common HCP Disputes and Resolutions including HCP Perspectives

• Unravel the Complexities of Travel Reimbursement Policies and Reporting

Information-Packed Sessions:20 Dedicated Tracks2

Comprehensive Workshops3

Mayo Clinic American Medical Assoc

The Medicines Company

U.S. Attorney’s Office, NJ AstraZeneca Astellas US Sarah Cannon

Research InstU.S. Attorney’s

Office, TNGE

Healthcare AlereJohnson & Johnson

Johnson & Johnson

Eli Lilly and Company Pfizer Inc

Register by 6/19/15 to Save $300!

CLE, CPE and CCB Credits Available!

Pending Approval

W W W . C B I N E T . C O M / T R A N S P A R E N C Y2

In December 2014, the CMS Open Payments database contained information for approximately 500,000 physicians and 1,360 teaching hospitals totaling $3.7 billion dollars,

according to iHealthBeat 1/23/15. For many people, those are merely statistics. For those of us attending this conference each year and responsible for ensuring accurate, efficient and compliant transparency reporting

in our respective organizations… it represents so much more.

This year, don’t miss CBI’s 9th Annual Forum on Transparency & Aggregate Spend as it taps into the topics you identified as “must-haves.” The program includes robust opportunities for networking and benchmarking with

industry counterparts to gather information on complex issues, including:

Why Attend?

A Look Into the Past 8 Years of CBI’s Annual Forum on Transparency and Aggregate Spend

2,200+total attendees

435+expert speakers

460+companies

have benefited

85%life sciences or

dental manufacturerrepresentation

69%attended with

colleagues

2014 Transparency and Aggregate Spend Attendee Profile

How to Correlate Transparency Data with Other Sources for Strategic Intelligence

Clinical Research Transparency Reporting Including How Value Is Assigned to Study Drugs

Ways to Strengthen Relationships with Teaching Hospitals and ACOs

Creating a Standardized Process for Validating and Verifying HCP and Third-Party Data

Innovative Use of Statistical Tools for Compliance Monitoring

Which Types of Published Transparency Data May Cause State and Federal Inquiries

Valuable HCP and Industry Perspectives on Dispute Resolution Best Practices

Understanding Implications of Open Payments on Speaker and KOL Engagement

The Reality of Building One System for Global Transparency Reporting

Status Report on Industry Implementation of the EFPIA Disclosure Code

...BY COMPANY TYPE...BY FUNCTION

45% Compliance / Legal

22% Transparency / Reporting

9% Medical / Clinical Affairs

8% Sales / Marketing / Commercial Operations

8% Finance

4% Business Analytics / Operations

4% Systems / Data

59% Bio / Pharma

23% Device / Dental

14% Service Providers

3% Academia

1% CROs

EFPIA Keynote Address in the Global Transparency Track:

Going Beyond the EFPIA Code — Delivering Greater Transparency

Andrew Powrie-Smith, Director of Communications, European Federation of Pharmaceutical Industries and Associations (EFPIA)

Esteemed Faculty Steven Arias,

Compliance Manager, Ironwood Pharmaceuticals

Davida Baker, Director Transparency Reporting, US Medical Affairs, AstraZeneca

Rebecca Bartron, Global Marketing, Compliance Manager, DENTSPLY International

Anthony Brennan, Senior Director Healthcare Compliance, Johnson & Johnson

David O. Barbe, M.D., MHA, Member and Past Chair, Board of Trustees, American Medical Association

Maya Babu, M.D., MBA, Member Board of Trustees, American Medical Association, Neurosurgery Resident, Mayo Clinic

Brian Bohnenkamp, Senior Associate, FDA and Life Sciences Practice, King & Spalding

Ryan Burger, Director, Science Unit Transparency Reporting, AstraZeneca

Ed Buthusiem, Managing Director, Berkeley Research Group

Jessica Campano, Manager, Data Strategy and Reconciliation – Transparency, Pfizer Inc

Gretchen Reyes Cseplo, Associate Director Ethics, Compliance and Transparency Operations, ConvaTec

Mark DeWyngaert, Managing Director,, Huron Consulting Group

Dawn DiPierro, Senior Manager, Compliance, Teva

Garineh Dovletian, Senior Vice President, Chief Risk Officer, The Medicines Company

Erik Eglite, D.P.M., J.D., MBA, Vice President, Chief Compliance Officer, Corporate Counsel, Lundbeck

Jacob T. Elberg, Chief, Health Care & Government Fraud Unit, United States Attorney’s Office, District of New Jersey

Judy Fox, Director, Transparency Compliance, CIS

Kira E. Geiss, CPP, APM, ARM, Director of Finance, Heraeus Kulzer, LLC

Francis Geysermans, Chief Technology Officer (CTO), BMI SYSTEM

Jodie Gillon, Head, External Interface Office, AstraZeneca

Toby Ann Holetz, Global Head, Global Aggregate Spend Reporting Team, Associate Director, Finance and Operational Risk Management, Quintiles

Bethany Hong, Director Grants Administration Finance, INC Research

Stacy M. Hornaday, Associate Compliance Director, Astellas US LLC

Denise P. Jones, Senior Counsel, Sarah Cannon Research Institute

Bill Killian, United States Attorney, Eastern District of Tennessee

Tom Kirkpatrick, Director and Practice Lead, Transparency, CIS

Christian Krautkramer, Global Compliance, GE Healthcare

Kenneth Lee, General Counsel, Benco Dental

Mark Linver, Managing Director, Huron Consulting Group

Kari K. Loeser, Senior Director & Senior Compliance Counsel, Jazz Pharmaceuticals

Gregory Maynard, Director, Transparency and Disclosure, LexisNexis® Health Care

Heather McCollum, JD, MHA, Director, Compliance, Shionogi Inc.

Christine Meyers, CFE, CHC, CCEP, Director, Global Compliance Program, Alere

John Murphy, Executive Vice-President and General Counsel, PhRMA

Gina Marie Nese, Chief Compliance Officer, KaVo Kerr Group Legal Department

John Patrick Oroho, Executive Vice President & Chief Strategy Officer, Porzio Life Sciences, LLC

Gus Papandrikos, Senior Director, Compliance Communications and Reporting, Daiichi Sankyo

Veleka Peeples-Dyer, Legal and Compliance Consultant

Andrew Powrie-Smith, Director of Communications, European Federation of Pharmaceutical Industries and Associations (EFPIA)

Steve Schmitt, Consultant, Global Transparency, Eli Lilly and Company

Dobson Schofield, Interim Head of Compliance US BU Global Compliance Office, Takeda Pharmaceuticals U.S.A., Inc.

Elizabeth Schwartz, Director, U.S. External Reporting and Transparency, Johnson & Johnson

Paul Silver, Managing Director, Practice Leader, Huron Consulting Group

Laura Skinner, Director, Huron Consulting Group

Tom Sullivan, President, Rockpointe

Kelly Tope, Director of Compliance, Biomet

Jeff Trull, Sunshine Act/Financial Systems Manager, Covance

Susan C. Viele, Director, Global Transparency Initiatives, Eli Lilly and Company

Ekaterina S. Walloe, Competency Development Professional, Clinical Operations, Novo Nordisk A/S

Rosemary Weghorst, Managing Director, Berkeley Research Group

Darryl Williams, Head of Global MDM and Platform Solutions, LexisNexis® Health Care

Gina Williams, Director, Medical Business Technology, External Medical Communications & Medical Regulatory Compliance, Pfizer Inc (invited) 3

D ay O ne — Monday, August 17, 2015

8:00 Registration for Workshop A

9:00-5:00 WORKSHOP A

12:30 Registration for Workshop B & C

1:30-5:00 WORKSHOP B & C

3:00 Networking and Refreshment Break

5:00 Close of Workshops / Wine and Cheese Reception Commences

D ay Two — Tuesday, August 1 8 , 2015

7:00Main Conference Registration and Continental Breakfast

8:00 Chairman’s Welcome and Opening Remarks

8:15CMS KEYNOTE ADDRESS An Update on Open Payments Reporting

9:00

PANEL DISCUSSION Strategies to Reduce Compliance Risks and Optimize Commercial Programs Using Transparency Data Analytics

9:45 Streamline Your Process for Remediation and Data Attestation

10:30 Networking and Refreshment Break

11:00State Disclosure Laws — Preemption, Enforcement and Continued Reporting Requirements

11:45PANEL DISCUSSION Update on Trends in Government Enforcement

12:30 Networking Luncheon

D A Y O N E W O R K S H O P S

A Transparency Reporting for Dental Manufacturers

BTransparency Reporting in Clinical Research — Optimizing Relationships with Teaching Hospitals and Academic Research Organizations

C Global Customer and Vendor Master Data Management

1:45PANEL DISCUSSION Most Common Disputes and How They’ve Been Resolved

2:30

PANEL DISCUSSION HCP Perspectives on Transparency Reporting — Impact and Opportunities Moving Forward

3:15Unravel the Complexities of Meetings and Travel Reimbursement Policies and Reporting

4:00 Networking and Refreshment Break

4:30

WORKING GROUP DISCUSSIONS

1 Ensure Data Integrity of the Customer Master

2 Timely Reporting of Indirect Payments — Working with Third-Party Vendors

3 Fair Market Value of HCP and Investigator Payments

4 Ensure Successful IT and Data Accuracy for Global Transparency

5 Navigate Compliance with CMS Final Rule Adjustments

6 Match and Validate Covered Recipient Data in Open Payments

6:15Close of Day Two | Wine and Cheese Reception

4

Agenda at a Glance

W W W . C B I N E T . C O M / T R A N S P A R E N C Y

D ay Three — Wednesday, August 1 9 , 2015

TRACK IGLOBAL TRANSPARENCY

PROGRAMS

7:30 Continental Breakfast

8:00Track Leader’s Welcome and Opening Remarks

8:15EFPIA KEYNOTE ADDRESS Going Beyond the EFPIA Code — Delivering Greater Transparency

9:00Status Report on Industry Implementation of the EFPIA Disclosure Code within a Global Context

9:45 Networking and Refreshment Break

10:15PANEL DISCUSSION Ensure a Consistent and Compliant Global Transparency Framework

11:00Incorporate Evolving Transparency Guidelines when Implementing a Global FMV Program

11:45Building a Global Transparency Solutions Center

12:30 Close of Track A / Luncheon

TRACK IIDATA ANALYTICS FOR

SHARED INTELLIGENCE

7:30 Continental Breakfast

8:00Track Leader’s Welcome and Opening Remarks

8:15Align Metrics and Analytics Across All Business Units

9:00Correlate Transparency Data with Other Data Sources for Strategic Intelligence

9:45 Networking and Refreshment Break

10:15PANEL DISCUSSION Leverage Open Payments Data to Minimize Risk

11:00CO-PRESENTATION How to Ensure Accurate Data — The Critical Key to Valuable Analytics

11:45CO-PRESENTATION Preparation for Potential Merger and Acquisition Data Reporting

12:30 Close of Track B / Luncheon

1:30 Live Polling Benchmarking Survey and Comparison Summary of Survey Results Over the Last Three Years

2:15 Recent Publication and Media Portrayal of 2014 Open Payments Data

3:00 Close of Conference

8:00 – 12:30 C H O O S E B E T W E E N T W O C O N C U R R E N T T R A C K S

W W W . C B I N E T . C O M / T R A N S P A R E N C Y 5

Agenda at a Glance

G E N E R A L S E S S I O N

9:00 Chairperson’s Welcome and Opening Remarks

Gina Marie Nese, Chief Compliance Officer, KaVo Kerr Group Legal Department

9:15 Compliance Considerations and Implications of Transparency• Understand the connection between the Open

Payments, Anti-kickback and False Claims Acts• Examine the legal rationale behind why reports made

under the Sunshine Act could result in potentially large awards to private pleaders under the False Claims Act

• Discuss the challenges associated with determining what is allowed under the Anti-kickback Act

• Suggestions and strategies for avoiding potential compliance issues

Kenneth Lee, General Counsel, Benco Dental

10:00 Deep Dive into Dental Data Analytics• What story does the data tell specific to

dental companies?• What are the compliance trends in the dental

industry based on the transparency data?• What types of internal auditing and monitoring

are necessary according to the analytics?• Examine third-party spend and identify

where the problems exist• Review transparency data for opportunities

to improve sales and marketing Gina Marie Nese,

Chief Compliance Officer, KaVo Kerr Group Legal Department

11:00 Networking Refreshment Break

11:30 Experience Is the Best Teacher — Key Takeaways from 2014 Open Payments Reporting• What are the best practices for scrubbing data?• Data integrity tips to avoid CMS errors• Aggregate spend system features to improve reporting• How were samples for dentists treated?• How were continuing education programs for

dentists reported?• What was the process for identifying and validating

dentists? Future? Rebecca Bartron,

Global Marketing Compliance Manager, DENTSPLY International

12:30 Networking Luncheon

1:30 Improve Systems for Data Collection, Preparation, Auditing and Open Payments Report Filing• Streamline data collection and preparation• Test and ensuring the accuracy of your

provider-related data• Set up processes for auditing and monitoring• Data attestation and remediation• Standardize templates, systems and processes Kira E. Geiss, CPP, APM, ARMm,

Director of Finance, Heraeus Kulzer, LLC

2:30 Networking Refreshment Break

3:00 Move Towards a Global Transparency Reporting System• Updates on transparency reporting requirements

and industry implementation in:* Europe * Latin America * Asia

• Build processes and systems that enable a global framework for managing transparency data

• Examine all data sources globally• Evaluate opportunities to standardize processes,

systems and templates• Align standards for ensuring data privacy• Understand EU trans-border data transfer options

and limitations Ed Buthusiem,

Managing Director, Berkeley Research Group

4:00 Determine Fair Market Value Calculations — Incorporate Compliance Protocol• Tools to streamline U.S. and Global FMV calculations• Build compensation programs with compliant

reporting practices• Develop a robust compensation program that

incorporates a detailed compliance protocol to reduce risk of anti-corruption

• Document and substantiate exceptions to your FMV policy in preparation for regulatory audit

• Assess the implications and heightened level of scrutiny with HCPs in single payer systems to avoid non-compliance with the FCPA

• Maximize Open Payments data to audit internal business practices to generate actionable FMV program reform

Rosemary Weghorst, Managing Director, Berkeley Research Group

5:00 Close of Workshop A

Transparency Reporting for Dental Manufacturers

Day One — Monday, August 17, 20158 :0 0 WO R KS H O P R EG ISTR ATIO N • 9 :0 0 WO R KS H O P CO M M EN C E S

SUPPORTING ORGANIZATION:

Please Join Us for a Networking Wine and Cheese Reception at the Close of the Workshops6

A

C H O O S E B E T W E E N T H R E E P R E - C O N F E R E N C E W O R K S H O P S

Workshop Objective:This workshop provides an examination of the essential elements for consideration when complying with the complexities of Open Payments reporting in pre-clinical and clinical research. Ideas for strengthening relationships with teaching hospitals and academic research organizations are discussed.

Key Questions to Be Addressed:• What are the best methods for building successful working

relationships with teaching hospitals and academic medical centers?• How should you analyze aggregate spend data to improve clinical

trial management?• What are best practices for managing clinical data collection and

reporting with CROs, SMOs and sites?• Are site management fees, CRO fees and administrative costs included?• How does reporting differ in commercial form compared to with

teaching hospitals?

Workshop Outline:

I. The Impact of Changes to the Final Open Payments Reporting on Clinical Research• What is considered a research payment?• How is value assigned to study drugs?• How do you support transparency strategies involving

global, multicenter clinical trials, as well as laws and codes which apply to investigators?

II. Establish FMV Payments and Expense for Investigators, CROs, SMOs, IRBs• Establish an efficient process for collecting and tracking

clinical spend• What is reportable with direct and indirect payments?• How do you trace the payment in clinical spend reporting?• How should we collect investigator grant payments

for reporting?

III. Effectively Manage the Relationship with Teaching Hospitals, Academic Research Organizations and Third-Parties• Identify recommended ways to manage the complexities

of working with third-parties• Determine best practices for dispute resolution

There will be a 30-minute networking break at 3:00pm

Workshop Leaders: Davida Baker,

Director Transparency Reporting, US Medical Affairs, AstraZeneca

Toby Ann Holetz, Global Head, Global Aggregate Spend Reporting Team, Associate Director, Finance and Operational Risk Management, Quintiles

Denise P. Jones, Senior Counsel, Sarah Cannon Research Institute

5:00 Close of Workshop B

7

Workshop Objective:This workshops provides the tools and techniques for understanding how to integrate multiple data streams and standardize processes for collecting, validating and verifying transparency data. Ensure that your system and process for managing master data, including global customer and vendor data, are a valuable asset to your organization.

Key Questions to Be Addressed:• What are best practices for creating a standardized

process for validating and verifying HCP and third-party data?

• Are there methods for standardizing templates, systems and processes across multiple business units and divisions?

• What are key steps for global data integration?• How do you manage data remediation across all business

lines?

Workshop Outline:

I. Create a Standardized Process for Validating and Verifying HCP and Third-Party Data• Standardize data from internal and

external sources to meet transparency reporting requirements

• Identify process for capturing clean data

II. Standardize Processes for Data Remediation, Certification and Attestation• Determine and validate the HCP data coming in

from various sources• Ensure a process for correcting errors

and attestation

III. Leverage the Customer Master • Examine HCP spend for predisclosure• Is there an MDM solution that can provide

matching on these providers even with a broad spectrum of sources?

• Are you validating your data from all of these sources into a transactional repository?

• If data is stored differently based on source type, how can you ensure that it is a match?

There will be a 30-minute networking break at 3:00pm

Workshop Leaders: Kelly Tope,

Director of Compliance, Biomet

Gus Papandrikos, Senior Director, Compliance Communications and Reporting, Daiichi Sankyo

5:00 Close of Workshop C

Day One — Monday, August 17, 201512 : 30 WO R KS H O P R EG ISTR ATIO N • 1 : 30 WO R KS H O P CO M M EN C E S

Transparency Reporting in Clinical Research — Optimizing Relationships with Teaching Hospitals and Academic Research Organizations

Global Customer and Vendor Master Data Management

Please Join Us for a Networking Wine and Cheese Reception at the Close of the Workshops

B C

C H O O S E B E T W E E N T H R E E P R E - C O N F E R E N C E W O R K S H O P S

Bethany Hong, Director Grants Administration, Finance, INC Research

Lisa Keilty, Global Vice President Compliance and Strategic Solutions, AHM

G E N E R A L S E S S I O N7:00 Main Conference Registration & Continental Breakfast

8:00 Chairman’s Welcome & Opening Remarks

Erik Eglite, D.P.M., J.D., MBA, Vice President, Chief Compliance Officer, Corporate Counsel, Lundbeck

8:15 CMS KEYNOTE ADDRESS An Update on Open Payments Reporting

Doug Brown, MHS, Group Director, Data Sharing & Partnership Group, Center for Program Integrity, Centers for Medicare & Medicaid Services (CMS)

9:00 Strategies to Reduce Compliance Risks and Optimize Commercial Programs Using Transparency Data AnalyticsGain perspectives on the reality of how to best use transparency data as a window into risk assessment and remediation, as well as competitive benchmarking and a tool for business growth. Discuss how transparency data and related intelligence fit into the overall compliance and commercial strategy.

• Innovative use of statistical tools for compliance monitoring

• Diagnose concerns in data integrity, quality controls and data review procedures

• Identify emerging areas where aggregate spend reporting may conflict or not align with other compliance policies or processes

• Use transparency reporting data analytics for the following:* defending product liability cases* differentiating the performance of

sales representatives * uncovering problematic relationships with HCPs* using data for compliance investigations * analyzing and comparing competitive spend

Moderator:

Garineh Dovletian, Senior Vice President, Chief Risk Officer, The Medicines Company

Panelists:

John Patrick Oroho, Executive Vice President & Chief Strategy Officer, Porzio Life Sciences, LLC

Heather McCollum, JD, MHA, Director, Compliance, Shionogi Inc.

Dobson Schofield, Interim Head of Compliance US BU Global Compliance Office, Takeda Pharmaceuticals U.S.A., Inc.

9:45 Streamline Your Process for Remediation and Data Attestation Determine the most efficient route and accompanying processes for correcting and resubmitting data. Build in continuous quality improvement methods to ensure accuracy.

• Understand CMS guidelines for ongoing data remediation and attestation

• Establish/update your process for remediation and attestation* document and communicate throughout

the organization• Effectively manage third-party vendors and their TOV

data as it pertains to data remediation and attestation• Provide efficient access to information and ensure a

standard process for communicating with HCPs• Understand how to mitigate risk in the process for

remediation and data attestation Gregory Maynard,

Director, Transparency and Disclosure,

LexisNexis® Health Care

10:30 Networking & Refreshment Break Hosted by:

11:00 State Disclosure Laws — Preemption, Enforcement and Continued Reporting RequirementsGain an update on developments at the state level on enforcement trends and future priorities.

• Overview of the breakdown of state reporting requirements and interpretations of regulations

• Recent activities in Connecticut, Vermont, D.C., West Virginia, Massachusetts and Minnesota

• Pending regulations• How is the published Open Payments data being

reviewed by state authorities?• What data may raise concern?• Opportunities for coordinating federal and

state reporting Brian Bohnenkamp,

Senior Associate, FDA and Life Sciences Practice, King & Spalding

11:45 CO-PRESENTATION Update on Trends in Government EnforcementHear firsthand about areas where enforcement may be considered.

• Update on recent enforcement priorities and status of:* False claims* Off-label* Anti-kickback* FCPA investigations

8

Day Two — Tuesday, August 18, 2015

PANEL

• Gain insight into what types of data and issues may cause an inquiry

• How to respond to government inquiries

Bill Killian,

United States Attorney,

Eastern District of Tennessee

Jacob T. Elberg,

Chief, Health Care & Government Fraud Unit,

United States Attorney’s Office, District of New Jersey

12:30 Networking Luncheon

1:45 Most Common Disputes and How They’ve Been Resolved

Gather valuable information on ensuring the success of your dispute resolution process. During this interactive panel, benefit from a comprehensive summary of the most common disputes and resolution.

• Is pre-disclosure a good idea and does it work?• Best practices for internal guidelines regarding

relationship management with HCPs• Tools and techniques for preserving strong

relationships with teaching hospitals and physicians• Opportunities for training sales reps to respond to

HCPs’ questions and concerns about disclosure data

Moderator:

Kari K. Loeser,

Senior Director & Senior Compliance Counsel,

Jazz Pharmaceuticals

Panelists:

Stacy M. Hornaday,

Associate Compliance Director,

Astellas US LLC

Jessica Campano,

Manager, Data Strategy and Reconciliation — Transparency,

Pfizer Inc

Gretchen Reyes Cseplo, Associate Director Ethics,

Compliance and Transparency Operations,

ConvaTec

2:30 HCP Perspectives on Transparency Reporting — Impact and Opportunities Moving Forward

Learn more about the physician’s perspective on transparency reporting and where opportunities exist to improve communication. Hear from physicians about their views on dispute resolution, pharmaceutical transparency and relationship management.

• What are best practices for communicating with physicians?

• What issues and areas are most problematic?• What has the physician’s experience with the

dispute process been like? • What is your experience and perspective of

pre-disclosure?• Do you recommend that manufacturers employ

predisclosure practices?Moderator:

John Murphy, Executive Vice-President and General Counsel, PhRMA

Panelists:

Maya Babu, M.D., MBA, Member Board of Trustees, American Medical Association, Neurosurgery Resident, Mayo Clinic

David O. Barbe, M.D., MHA, Member and Past Chair, Board of Trustees, American Medical Association

3:15 Unravel the Complexities of Meetings and Travel Reimbursement Policies and ReportingThere are numerous details involved in travel reimbursement which provide complications and confusion with regard to Sunshine Reporting. Benefit from hearing how others are managing travel reimbursement reporting.

• Identify a process for gathering data needed• Discover how to organize reporting requirements

with outsourced logistics companies• Examine methods for liaising with internal

conference team• Best practices for meetings, system integration,

compliance and HCP relationshipsModerator:

Paul Silver, Managing Director, Practice Leader, Huron Consulting Group

Panelists:

Michelle Kaminski, Conference Project Manager, Global Conference Team, AstraZeneca

Marlize Eckert, Head of Compliance and Revenue Relations, Global Conference Organizers (GCO) (invited)

Laura Skinner, Director, Huron Consulting Group

4:00 Networking & Refreshment Break

9

Day Two — Tuesday, August 18, 2015

PANEL

PANEL

PANEL

1 Ensure Data Integrity of the Customer Master

• Best practices for validating and verifying customer data

• Lock down systems to ensure accuracy• Ensure the integrity of the customer master

with regard to access and expense reporting• Audit and monitoring practices• Work with your vendors to maintain

data integrity

Facilitator:

Dawn DiPierro,

Senior Manager, Compliance, Teva

2 Timely Reporting of Indirect Payments — Working with Third-Party Vendors

• Commercial, medical and clinical contracting• Ensure complete, accurate and timely reporting

of third-party spend details• Contractual changes as a result of Open Payments• Promoting use of preferred vendors• Accountability for collecting and archiving info

that may be needed for dispute resolution

Facilitator:

Jeff Trull,

Sunshine Act/Financial Systems Manager,

Covance

3 Fair Market Value of HCP and Investigator Payments

• Process, internal controls and integrated systems to manage payments

• Strategies to ensure proper transparency• Understand implications of Open Payments on

speaker and KOL engagements• Global FMV

Co-Facilitators:

Davida Baker,

Director Transparency Reporting,

US Medical Affairs,

AstraZeneca

Susan C. Viele,

Director, Global Transparency Initiatives,

Eli Lilly and Company

4 Ensure Successful IT and Data Accuracy for Global Transparency• Is it necessary to have multi-systems for transparency

or possible to have one IT framework for global transparency?

• Consider centralized and decentralized data capture • Overcome operational aspects of IT management

Facilitator:

Darryl Williams, Head of Global MDM and Platform Solutions, LexisNexis® Health Care

5 Navigate Compliance with CMS Final Rule AdjustmentsHow have companies made, and continue to make, changes to ensure compliance with CMS final rule adjustments to be implemented for 2016 data collection?

• Participation status of Spring CME events• Understand changes, if any, to speaker fees and other

adjustments to processes and practices• Status of vendor alignment and master data

management ensuring consistent data in the future• Navigate the challenges of the implementation of

reporting marketed name of medical devices Elizabeth Schwartz,

Director, U.S. External Reporting and Transparency, Johnson & Johnson

6 Match and Validate Covered Recipient Data in Open Payments• Overview of CMS matching process and matching logic • Understand the challenge of working with the validated

physician list • Share common areas of problems and

brainstorm solutions• Best practices for iterating through the

matching process• Prioritize suggestions for CMS on how to improve

the matching algorithm Facilitator:

Steve Schmitt, Consultant, Global Transparency, Eli Lilly and Company

6:15 Close of Day Two

6:15 Please join us for a wine & cheese reception immediately following the last session

10

Working Group Discussions

Identify Common Challenges and Develop Best PracticesChoose one of the themes offered that speaks directly to your interests. Working groups provide a great environment for participants to hear first-hand from peers about challenges and experiences throughout the industry. Each working group is led by a facilitator helping to drive the discussion surrounding the practical issues behind these topics.

4:30 CHOOSE FROM SIX WORKING GROUPS (1-6)

8:00 Track Leader’s Welcome and Opening Remarks

Christine Meyers, CFE, CHC, CCEP, Director, Global Compliance Program, Alere

8:05 EFPIA KEYNOTE ADDRESS Going Beyond the EFPIA Code — Delivering Greater TransparencyBenefit from an update on the implementation of the EFPIA Code and a look at the issues, challenges and opportunities in delivering greater transparency across 33 countries.• Recommended best practices for implementing

EFPIA’s code• Efforts to explain transparency objectives

to healthcare professionals and healthcare organizations

• Role of EFPIA’s dedicated website — www.pharmadisclosure.eu

Andrew Powrie-Smith, Director of Communications, European Federation of Pharmaceutical Industries and Associations (EFPIA)

8:45 Status Report on Industry Implementation of the EFPIA Disclosure Code within a Global Context Obtain a progress report on the implementation of EFPIA’s Disclosure Code. Hear first-hand about both the pitfalls and successful momentum involved in developing a global strategy for transparency reporting compliance.• How are companies implementing French Sunshine

Law and EFPIA code?• Tips for managing local to global compliance• Examples of how data is collected and processed

for compliance throughout Europe• Examine the data retention requirements in France

and throughout Europe• Strategies for managing communication with

HCOs and HCPs• Understand pitfalls involved in implementing systems

that can handle data processing at both local and global levels

Francis Geysermans, Chief Technology Officer (CTO), BMI SYSTEM

9:25 Cross Border and Unique Country Identifiers• Learn the challenges with cross border spend and

how best to manage it• What are the data privacy considerations for cross

border spend?• Understand about unique country identifiers in

EFPIA templates• Examine which countries have these identifiers

required for EFPIA and learn the key takeaways Don Soong,

Vice President, Strategic Solutions, IMS Health

Priyanka Sharma, Director, Product Development, Compliance Products, IMS Health

10:05 Networking & Refreshment Break

8:00 Track Leader’s Welcome and Opening Remarks

Anthony Brennan, Senior Director Healthcare Compliance, Johnson & Johnson

8:15 Align Metrics and Analytics Across All Business UnitsCreate new process metrics and business analytics that can be used to improve accuracy, effectiveness and efficiency of transparency programs.• Align metrics to ensure useful data intelligence• Create user-friendly dashboards that show

real-time analytics• Use metrics and analytics to flag areas of

immediate concern Mark Linver,

Managing Director, Huron Consulting Group

Anthony Brennan, Senior Director Compliance, Johnson & Johnson

9:00 Correlate Transparency Data with Other Data Sources for Strategic IntelligenceA critical opportunity exists for relating transparency data with data in other areas of the business to evaluate potential cause and effect or a more comprehensive way to analyze the whole picture.• Identify other areas of the business and data

sources for overlaying • Create tools to demonstrate relationships

between the data• Share intelligence and initialize the strategy

for improving the commercial business and compliance monitoring based on the data connections

Tom Kirkpatrick, Director and Practice Lead, Transparency, CIS

Judy Fox, Director, Transparency Compliance, CIS

9:45 Networking & Refreshment Break

10:15 Leverage pen Payments Data to Minimize Risk A review of disclosed data provides an opportunity to determine where Open Payments data may cause additional scrutiny and insight on how to better prepare for future reporting.

• How to apply data analytics to compliance monitoring

• Using analysis to defend product liability cases• Anti-kickback• Examining sales data

TRACK I

Global Transparency Programs

TRACK II

Data Analytics for Shared Intelligence

11

Day Three — Wednesday, August 19, 20157:30 CONTINENTAL BREAKFAST 8:00 CHOOSE BETWEEN TWO CONCURRENT TRACKS

PANEL

10:35 Ensure a Consistent and Compliant Global Transparency FrameworkLearn more about how to implement processes and systems that support a global framework for managing compliance with transparency reporting guidelines. • Avoid building redundant systems and processes• Understand the process for managing consent• Examine global standards for data validation

and verification• Evaluate opportunities to standardize processes,

systems and templates• Assess opportunities for maximizing

resource management Ryan Burger,

Director, Science Unit Transparency Reporting, AstraZeneca

Christian Krautkramer, Global Compliance, GE Healthcare

Ekaterina S. Walloe, Competency Development Professional, Clinical Operations, Novo Nordisk A/S

11:15 Incorporate Evolving Transparency Guidelines when Implementing a Global FMV ProgramBuild a transparency methodology for determining fair market value globally.

• Establish a global FMV policy which takes into consideration national and international reporting regulations

• Document exceptions to your organization’s FMV policy

• Analyze the ramifications of major differences in payment between companies — What will this mean for payment practices in the industry?

• Confirm that your company’s method is transparent and consistent

• Establish a clinical trial investigator FMV framework• Determine a comprehensive FMV calculation• Ensure that your FMV policy reduces compliance risks Mark DeWyngaert,

Managing Director,

Huron Consulting Group

11:55 Building a Global Transparency Solutions Center• Transparency guidelines continue to emerge

around the world — Consider whether or not you want to develop one system that is built to meet transparency requirements globally

• Build systems to accommodate different types of disclosure initiatives — EFPIA, JPMA, Australia, Nordic, Australia

• Address access controls for global transparency reporting systems

• Understand why one system helps to control costs and ensure quality

• Considerations for building the data warehouse• Ensure successful customer data matching Gina Williams, Director, Medical Business Technology, External

Medical Communications & Medical Regulatory Compliance, Pfizer inc (invited)

12:30 Close of Tracks / Networking Luncheon

• Opportunities for auditing and monitoring• Minimize risks in speaker program and advisory

board spend• Decrease risk of compliance penalties

Moderator:

Gina Marie Nese, Chief Compliance Officer, KaVo Kerr Group Legal Department

Panelists:

Stacy M. Hornaday, Associate Compliance Director, Astellas US LLC

Kari K. Loeser, Senior Director & Senior Compliance Counsel, Jazz Pharmaceuticals

Kelly Tope, Director of Compliance, Biomet

11:00 CO-PRESENTATION How to Ensure Accurate Data — The Critical Key to Valuable Analytics Identify the gaps in your process and systems to ensure quality data from the start.

• Data integration — How to ensure accuracy when integrating multiple data streams

• Verification and validation strategies• Implement a process for error reduction• Audit and monitor data at source systems Steven Arias,

Compliance Manager, Ironwood Pharmaceuticals

Heather McCollum, JD, MHA, Director, Compliance, Shionogi Inc.

11:45 CO-PRESENTATION Preparation for Potential Merger and Acquisition Data Reporting There are unique issues and concerns for transparency reporting in the context of mergers and acquisitions. Learn more about how to build a framework to manage the data integration and reporting demands post M&A.

• Identify process, data and system differences • Determine the most vulnerable areas for

system integration• Leverage best practices from

previous operations• Standardize processes and procedures• Integrate multiple data streams into new

or revised systems and processes• Educate and train key stakeholders Ed Buthusiem,

Managing Director, Berkeley Research Group

Rosemary Weghorst, Managing Director, Berkeley Research Group

12

TRACK I CONTINUED TRACK II CONTINUED

3:00 Close of Conference

13

1:30 Live Polling Benchmarking Survey and Comparison Summary of Survey Results Over the Last Three Years

Each year at this meeting, attendees use a live polling

system to benchmark interpretations of requirements,

as well as progress on the capture and reporting

process of their aggregate spend solutions. Results

of the benchmarking questions are shared in real–time

and compared with the answers to past years’ results.

This session is an excellent opportunity to examine

industry trends with regard to changes in strategy,

process and systems.

Veleka Peeples-Dyer,

Legal and Compliance Consultant

2:15 Recent Publication and Media Portrayal of 2014 Open Payments Data

Gain perspective on the most recently

published 2014 Open Payments data and what

we’ve learned about the media’s interest in and

coverage of the data.

• Review data points recently published

• Examine the latest media portrayal of

aggregate spend data

• Develop strategies for your transparency initiative and

business going forward — What can we expect next?

Tom Sullivan,

President, Rockpointe

GENERAL SESSION

“A great conference leaves you thinking and inventing new processes for innovating. CBI hit it out of the park.”— Compliance Audit Manager, Grifols, Inc.

“I met a lot of peers, made new friends and expanded my compliance connections. Excellent dialogue and time for networking.” — Director of Corporate Compliance, Endologix

“This conference is very beneficial as it provides a good beginning understanding of the requirements and reinforces practices already in use.” — Aggregate Spend Coordinator, Shire

“I came into the Agg Spend discussion late in the game. The conference helped me see what we’ve done right so far, but helped me to identify the important steps we still need to do.” — VP Sales and Marketing, Validus Pharmaceuticals

Who Should AttendYou will benefit from attending this event if you work for an applicable manufacturer or GPO, including those from pharmaceutical, biotech, medical device, dental, medical supply or distributors with responsibilities or involvement in the following areas:

• Transparency• Compliance • Finance• Global Transparency• Aggregate Spend• Commercial Operations• HCP Reporting• Risk Management• Business Analytics• Legal Affairs• Regulatory Affairs• External Reporting• Healthcare Compliance• Clinical Operations• Clinical Research• Medical Affairs• Audit & Monitoring• Strategy• Master Data Management• IS/IT• Enterprise Architecture• State Reporting

MEDIA PARTNERS

Acclaim from Previous Attendees

TECHNOLOGY LEADERS CIRCLE

Silver Sponsor

LexisNexis® Health Care solves life science’s provider information problems with correct, current and comprehensive provider information solutions. Better data means better provider database management, improved regulatory compliance and enhanced marketing optimization.

Learn more at www.lexisnexis.com/risk/health-care/.

CONSULTING LEADERS CIRCLE

Bronze Sponsor

Huron Life Sciences serves pharmaceutical, medical device and biotechnology companies, healthcare providers, academic medical centers and the law firms and investment firms that support these organizations to achieve financial, operational and strategic objectives. Learn more at www.huronconsultinggroup.com/lifesciences or follow us on Twitter: @Huron.

For more information about Huron Life Sciences or to continue the conversation after the conference, please contact Paul Silver at 678-672-6160 or psilver@huronconsultinggroup.com.

DISTINGUISHED SPONSORSMeetings & Events International is a full service meeting and speaker management, training and aggregate spend reporting company providing sustainable compliant solutions to the life sciences industry. At Meetings & Events International, we partner with our clients to ensure every event is compliant. Our meeting services, analytics and online solutions can help you create memorable events that you will be proud to report. Our service is so clear-it’s transparent!

Alanda Software is a SaaS company that provides Global Data Quality & Reporting Transparency Solutions.

Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought leadership and sharing expertise.

ADDITIONAL SPONSORS & EXHIBITORS

W W W . C B I N E T . C O M / T R A N S P A R E N C Y14

Sponsors & Exhibitors

For additional information on sponsorship or exhibit opportunities, please call

Alexa Moore (339) 298-2107 alexa.moore@cbinet.com

Jamie McHugh (339) 298-2106 jamie.mchugh@cbinet.com

VENUE

The Ritz-Carlton, Washington DC

1150 22nd Street, NW

Washington, DC 20037

Phone Reservations: 800-241-3333

Hotel Direct Line: 202-835-0500

SUBSTITUTION & CANCELLATION

Your registration may be transferred to

a member of your organization up to

24 hours in advance of the conference.

Cancellations received in writing on

or before 14 days prior to the start

date of the event will be refunded,

less a $399 administrative charge. No

refunds will be made after this date;

however, the registration fee less the

$399 administrative charge can be

credited to another CBI conference

if you register within 30 days from

the date of this conference to an

alternative CBI conference scheduled

within the next six months. In case of

conference cancellation, CBI’s liability

is limited to refund of the conference

registration fee only. CBI reserves the

right to alter this program without

prior notice. Please Note: speakers and

agenda are subject to change. In the

event of a speaker cancellation, every

effort to find a suitable replacement

will be made without notice. The

opinions of the conference faculty do

not necessarily reflect those of the

companies they represent or CBI.

ACCOMMODATIONS:

To receive CBI’s special discounted

hotel rate:

Online: cbinet.com/transparency

Phone reservations: 800-241-3333

(Mention CBI’s Transparency and

Agg Spend)

Book Now! The Ritz-Carlton is accepting

reservations on a space and rate availability

basis. Rooms are limited so please book

early. All travel arrangements are subject

to availability.

TEAM DISCOUNT:

For every three paying registrations

from your company, you will receive a

fourth complimentary* registration to

the conference (must register four at

same time to qualify). To receive the

team discount you must register with our

customer service department by calling

339-298-2100.

* Advantage pricing rates do apply when applicable.

Offer may not be combined with any other special pricing

promotions. Offer may be used at CBI co-located events.

SATISFACTION GUARANTEED:

CBI stands behind the quality of its

conferences. If you are not satisfied with

the quality of the conference, a credit

will be awarded towards a comparable

CBI conference of your choice. Please

contact 800-817-8601 for further

information. Advanced preparation for

CBI conferences is not required.

PHONE800.817.8601

3 EASY WAYS TO REGISTER

WEBSITE:cbinet.com/transparency

1 2EMAIL

cbireg@cbinet.com

3

REGISTRATION FEE:

ADVANTAGE PRICING BY 6/19/15

Conference Only $1,999 Conference + Workshop $2,299 Dental Workshop Only $300

STANDARD PRICING AFTER 6/19/15

Conference Only $2,299 Conference + Workshop $2,599 Dental Workshop Only $300

ONSITE PRICING

Conference Only $2,399 Conference + Workshop $2,699 Dental Workshop Only $400

CHOOSE BETWEEN

Dental Workshop A

Workshops B C

Tracks I II

Discussion 1 2 3 4 5 6

Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation.

Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted. Verification for Corporate and Third-Party may be required.)

PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate.

15

PC15156

Sponsors & Exhibitors Registration

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Mayo Clinic

American

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U.S. Attorney’s Office, NJ

AstraZenecaAstellas US

Sarah Cannon Research Inst

U.S. Attorney’s Office, TN

Jazz Pharm

aceuticalsAlere

ConvaTecJohnson & Johnson

Mayo Clinic

American

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AstraZenecaAstellas US

Sarah Cannon Research Inst

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Company

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• E

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• N

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• R

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• Tran

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20

ANY QUESTIONS OR TO REGISTERCALL Juliet Nelson 339-298-2140

or FAX TO MY ATTENTION 781-939-2696email: juliet.nelson@cbinet.com